CLC number:
On-line Access: 2024-08-27
Received: 2023-10-17
Revision Accepted: 2024-05-08
Crosschecked: 0000-00-00
Cited: 0
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Yuanyuan Ge, Meng Cao, Hui Cao, Bin Han, Jingchen Zhang, Zhengyu Yi, Yaowei Wu, Beifen Zhu, Keping Ruan, Yiyi Pu, Yi Zeng, Tongjing Tao, Zhenzhong Lyu, Hongmei Yuan & Guiliang Chen. Pharmaceutical digital transformation in China: digital quality assurance takes the driver’s seat[J]. Journal of Zhejiang University Science D, 2023, 6(5): 609–615.
@article{title="Pharmaceutical digital transformation in China: digital quality assurance takes the driver’s seat",
author="Yuanyuan Ge, Meng Cao, Hui Cao, Bin Han, Jingchen Zhang, Zhengyu Yi, Yaowei Wu, Beifen Zhu, Keping Ruan, Yiyi Pu, Yi Zeng, Tongjing Tao, Zhenzhong Lyu, Hongmei Yuan & Guiliang Chen",
journal="Journal of Zhejiang University Science D",
volume="6",
number="5",
pages="609–615",
year="2023",
publisher="Zhejiang University Press & Springer",
doi="10.1007/s42242-023-00248-0"
}
%0 Journal Article
%T Pharmaceutical digital transformation in China: digital quality assurance takes the driver’s seat
%A Yuanyuan Ge
%A Meng Cao
%A Hui Cao
%A Bin Han
%A Jingchen Zhang
%A Zhengyu Yi
%A Yaowei Wu
%A Beifen Zhu
%A Keping Ruan
%A Yiyi Pu
%A Yi Zeng
%A Tongjing Tao
%A Zhenzhong Lyu
%A Hongmei Yuan & Guiliang Chen
%J Journal of Zhejiang University SCIENCE D
%V 6
%N 5
%P 609–615
%@ 1869-1951
%D 2023
%I Zhejiang University Press & Springer
%DOI 10.1007/s42242-023-00248-0
TY - JOUR
T1 - Pharmaceutical digital transformation in China: digital quality assurance takes the driver’s seat
A1 - Yuanyuan Ge
A1 - Meng Cao
A1 - Hui Cao
A1 - Bin Han
A1 - Jingchen Zhang
A1 - Zhengyu Yi
A1 - Yaowei Wu
A1 - Beifen Zhu
A1 - Keping Ruan
A1 - Yiyi Pu
A1 - Yi Zeng
A1 - Tongjing Tao
A1 - Zhenzhong Lyu
A1 - Hongmei Yuan & Guiliang Chen
J0 - Journal of Zhejiang University Science D
VL - 6
IS - 5
SP - 609–615
EP -
%@ 1869-1951
Y1 - 2023
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1007/s42242-023-00248-0
Abstract: The development of automation, the Internet of Things (IoT), artificial intelligence (AI), big data, and other digital technologies has made it imperative for pharmaceutical companies to undergo digital transformation to improve their research and development capabilities, increase the quality of their products, lower operating costs, and gain a competitive edge. One of the most crucial steps in the life-cycle risk management chain for drugs is digital quality assurance (DQA). Based on a literature review, questionnaire survey, and expert consensus, a panel of experts was convened in Shanghai to generate a set of conceptual, pharmaceutical manufacturing-specific DQA specifications. The goal of the consensus is to advance common practices that use digital tools to quickly collect, record, evaluate, and review particular forms of data to enhance the automation of quality assurance and make drug quality activities more efficient.
Open peer comments: Debate/Discuss/Question/Opinion
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